Okay I have been wavering between tissue and mechanical, but I believe the best option for me is the mechanical route. Every one here as convinced me Coumadin is not a big deal and my cardiologist tells me mechanical is the way. So my question is what is the best mechanical valve? Pros/cons? I would like to have some options to discuss with my surgeon/cardiologist in 2 weeks and do some research on as well. Thank you for all your help.
Most likely going with a mechanical .
- Thread starter Buckeye
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You didn't list your age, but unless you're 90 years old, a prosthetic valve is probably the best way to go (in my own, entirely personal, opinion). No - coumadin/warfarin is really not that big a deal.
As far as the 'best' valve - I can make no recommendations. There are a few valves with decades of positive results - and these should be a very safe choice. The On-X is a newer valve, with a shorter track record (because it doesn't have the decades of patient outcomes to refer to).
On-X may have a more aggressive marketing campaign to physicians - probably necessary because it's the 'new valve on the block,' - but, like the others, it's FDA approved, is generating a track record, and may be an equally good choice versus the tried and true predecessors. With any mechanical valve (including On-X) it's probably safest to maintain an INR target of 3.0 +/- .5.
I'm sorry that this response hasn't shed much light (if any) on your decision. And even if you decide now, your surgeon may make a more appropriate decision during surgery. Be assured that there are many extremely good valves from which to choose.
You should be fine, regardless of the choice that you or your surgeon make.
As far as the 'best' valve - I can make no recommendations. There are a few valves with decades of positive results - and these should be a very safe choice. The On-X is a newer valve, with a shorter track record (because it doesn't have the decades of patient outcomes to refer to).
On-X may have a more aggressive marketing campaign to physicians - probably necessary because it's the 'new valve on the block,' - but, like the others, it's FDA approved, is generating a track record, and may be an equally good choice versus the tried and true predecessors. With any mechanical valve (including On-X) it's probably safest to maintain an INR target of 3.0 +/- .5.
I'm sorry that this response hasn't shed much light (if any) on your decision. And even if you decide now, your surgeon may make a more appropriate decision during surgery. Be assured that there are many extremely good valves from which to choose.
You should be fine, regardless of the choice that you or your surgeon make.
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The On-X valve was designed by a team of ex St-Jude Designers using a different technical characteristic,
it differs from all the others in the fact that it opens at 90 degrees, and that according to my surgeon is
the reason "if mechanical is chosen" he only implants On-X and that is what i got. Nothing wrong with the older
designs, On-X is just a little improved St Jude according to specialists, see attached document. I was going to
choose a Tissue valve at 62, but based on the attached info docs and conversation with my surgeon i went
with On-X, again, that is "the only" mechanical valve my surgeon would consider in XXI. Hope this helps,
Again, nothing wrong with older designs with proven records, but again, is people who designed the St Jude
who created On-X, All the best,
it differs from all the others in the fact that it opens at 90 degrees, and that according to my surgeon is
the reason "if mechanical is chosen" he only implants On-X and that is what i got. Nothing wrong with the older
designs, On-X is just a little improved St Jude according to specialists, see attached document. I was going to
choose a Tissue valve at 62, but based on the attached info docs and conversation with my surgeon i went
with On-X, again, that is "the only" mechanical valve my surgeon would consider in XXI. Hope this helps,
Again, nothing wrong with older designs with proven records, but again, is people who designed the St Jude
who created On-X, All the best,
Attachments
nobog
Well-known member
"the people" you are referring to is Dr. Jack Bokros, PhD, and he developed the carbon process for heart valve applications including the SJM valve - now On-X claims their carbon is significantly different. It is unclear how much involvement, if any, as to the design of the original SJM valve that he had.
pellicle
Professional Dingbat, Guru and Merkintologist
Hi
firstly I don't know if you read this response by nobog, but reading what nobog has written he clearly knows his stuff. You can get that feeling when discussing something with someone who does, and its distinct from the (often times) emotionally laden and anxiety driven "beliefs" which people hold fast to and espouse strongly.
Myself when I was making my valve choice (I had a few months to think about it) the On-X came up in my own readings and I wrote this blog post about my feelings. I anticipate you are going through some of those too.
In that post I wrote the following: "The other choice that the surgeon seems to be considering will be the one from ATS Medical (also pyrolytic carbon). Since he (rather than me) has more experience in this matter (implanting valves) I'll be relying on him to make the final choice "when he's in there and sees what he finds". "
I still believe that to be the best choice (to leave that decision to the surgeon. The reality is that each of On-X, ATS/Carbomedics , St Jude and other bileaflet pyrolytic carbon valves are iterative tweaks of eachother. I can send you (if interested) studies done to compare issues like "platelet activation" pressures that happen at the moment of valve opening or valve closing (just like putting your thumb over the hose). Those studies indicate while A does better than B on (say) opening, that the B in turn does better on closing. Yep, if you improve one feature the others slide.
So if your chosen surgeon has lots of experience with a valve, then he'll work better with that valve.
I'd pose the above discussion to your Cardio and see what they say.
Best Wishes
firstly I don't know if you read this response by nobog, but reading what nobog has written he clearly knows his stuff. You can get that feeling when discussing something with someone who does, and its distinct from the (often times) emotionally laden and anxiety driven "beliefs" which people hold fast to and espouse strongly.
Myself when I was making my valve choice (I had a few months to think about it) the On-X came up in my own readings and I wrote this blog post about my feelings. I anticipate you are going through some of those too.
In that post I wrote the following: "The other choice that the surgeon seems to be considering will be the one from ATS Medical (also pyrolytic carbon). Since he (rather than me) has more experience in this matter (implanting valves) I'll be relying on him to make the final choice "when he's in there and sees what he finds". "
I still believe that to be the best choice (to leave that decision to the surgeon. The reality is that each of On-X, ATS/Carbomedics , St Jude and other bileaflet pyrolytic carbon valves are iterative tweaks of eachother. I can send you (if interested) studies done to compare issues like "platelet activation" pressures that happen at the moment of valve opening or valve closing (just like putting your thumb over the hose). Those studies indicate while A does better than B on (say) opening, that the B in turn does better on closing. Yep, if you improve one feature the others slide.
So if your chosen surgeon has lots of experience with a valve, then he'll work better with that valve.
I'd pose the above discussion to your Cardio and see what they say.
Best Wishes
I applaud your choice of mechanical, but can't really comment on valve choice - my valve was done under the UK's NHS as something of an emergency and I was not offered a choice of mechanical valves; they went with a St Jude. The NHS is a very bureaucratic organisation where I suspect good value and reliability factors dominate, so I would suggest that a St Jude is a safe choice but might not be latest technology. For me these are good things.
Personally I think insisting on being able to self test your INR (Probably not for the first few months) and making sure your target INR range is not at the lower end is a more important factor than the make of the valve. From what I have read on this site over the last 5 years or so, and as somebody who does not do higher risk activities such as rock climbing or racing cars I am happy with an INR range of 2.5 to 3.5 being higher than others might think necessary, both because it is what my surgeon recommended and because I see no harm in being a little higher, in the interests of minimising a thrombosis.
Personally I think insisting on being able to self test your INR (Probably not for the first few months) and making sure your target INR range is not at the lower end is a more important factor than the make of the valve. From what I have read on this site over the last 5 years or so, and as somebody who does not do higher risk activities such as rock climbing or racing cars I am happy with an INR range of 2.5 to 3.5 being higher than others might think necessary, both because it is what my surgeon recommended and because I see no harm in being a little higher, in the interests of minimising a thrombosis.
Has anyone heard of a company called foldax that makes a new valve called the tria valve . It’s a mechanical valve that requires no anti coagulation drugs. It has been implanted in one human subject in Michigan, but I can’t find any information if it is available for new aortic patients yet. Any information/ links would be appreciated. Hoping to talk to my surgeon about the possibility of this valve vs the on x . Here is the link that I found on the company and valve.
https://foldax.com/
https://foldax.com/
pellicle
Professional Dingbat, Guru and Merkintologist
It isn't even at the trial stage yet. Probably at least a decade away.
https://clinicaltrials.gov/ct2/show/NCT03851068
Warrick
Well-known member
https://www.valvereplacement.org/threads/foldax-valve-trials.887288/#post-892891
Read the above thread, correct @Buckeye , so they have implanted it via TARV I think but cant confirm in one person, and I would guess by now theres been more implanted.
Just my guess but I would think if all goes well it could be 5-10 yrs and it will be well and truly mainstream.
Read the above thread, correct @Buckeye , so they have implanted it via TARV I think but cant confirm in one person, and I would guess by now theres been more implanted.
Just my guess but I would think if all goes well it could be 5-10 yrs and it will be well and truly mainstream.
It's been written about on this forum before. If I recall, it's a 3D printed valve that's made of a plastic material (I'm not sure which synthetic material) and isn't supposed to require anticoagulants after implantation.
The link that Pellicle posted will give you more information.
As Warrick noted, it'll be years before it's approved for transplantation into humans -- IF it's approved.
The link that Pellicle posted will give you more information.
As Warrick noted, it'll be years before it's approved for transplantation into humans -- IF it's approved.
They have already transplanted it in a man from Michigan in July from what I’ve read on the site. If that’s the case how much longer before mainstream. I’m not familiar with the time frame of early feasibility to clinical trials to fda approval.
Last edited:
nobog
Well-known member
This in not a new valve/concept. The industry has looked at this for decades. A minimum of 10 years before FDA approval (that's FDA approval - other countries have different requirements and IF it turns out to be the wonder valve, it could be sooner - but not by much).
carolinemc
Well-known member
I have had no issues with my St. Judes' leaflet valve. Been on Warfarin and no problems. Testing is not problem either. Just eat what you usually eat consistently and when you are more active and the taking of antibiotics that can affect your INR. Otherwise, normal life.
pellicle
Professional Dingbat, Guru and Merkintologist
me neither but the wording of that link to the Feasibility Study (note, not even a clinical trial) I sent above makes this clear:
| Estimated Study Completion Date : | December 2024 |
so maybe at the earliest 2025 could be the start of the clinical trials ... then after that's evaluated it may move forward ... say 2035?
2035 is scary.
By then, our planet may be in extreme trouble -- and this is probably not negotiable.
I'll be extremely surprised if I'm around another 15 years.
Many of our children, or grandchildren, or perhaps great-grandchildren may be beneficiaries of the new valve - if it receives approval and if the process of testing doesn't crash and burn along the way, relegating the valve to a subset of the population who can benefit from it.
By then, technologies may have improved enough that, only in rare cases, the chest would have to be cracked open and a new valve installed -- by then, improved, less invasive methods may have been developed. The competition for the necessity of this valve may have rendered it less important in 2035 than it is today.
By then, perhaps a new drug that doesn't cost as much as a Tesla payment will come along and reduce or eliminate the need for warfarin. By then, other techniques for dealing with bad valves will make warfarin unnecessary, except for the antiques (like me and others on this forum), who must still take warfarin.
And, by then, we may not have much of a world to live in, so we can take full advantage of these medical advancements.
Perhaps, if this valve shows tremendous promise, and makes it obvious to regulatory authorities that it's a superior alternative to the current mechanical valves, it will gain approval and adoption before too long.
This skeptic (realist?) may not be around to see it -- but it should be interesting to people who care about this stuff.
By then, our planet may be in extreme trouble -- and this is probably not negotiable.
I'll be extremely surprised if I'm around another 15 years.
Many of our children, or grandchildren, or perhaps great-grandchildren may be beneficiaries of the new valve - if it receives approval and if the process of testing doesn't crash and burn along the way, relegating the valve to a subset of the population who can benefit from it.
By then, technologies may have improved enough that, only in rare cases, the chest would have to be cracked open and a new valve installed -- by then, improved, less invasive methods may have been developed. The competition for the necessity of this valve may have rendered it less important in 2035 than it is today.
By then, perhaps a new drug that doesn't cost as much as a Tesla payment will come along and reduce or eliminate the need for warfarin. By then, other techniques for dealing with bad valves will make warfarin unnecessary, except for the antiques (like me and others on this forum), who must still take warfarin.
And, by then, we may not have much of a world to live in, so we can take full advantage of these medical advancements.
Perhaps, if this valve shows tremendous promise, and makes it obvious to regulatory authorities that it's a superior alternative to the current mechanical valves, it will gain approval and adoption before too long.
This skeptic (realist?) may not be around to see it -- but it should be interesting to people who care about this stuff.
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Protimenow: Is a sad reality for the future, but i agree 100% withr you, sort of like Jimmy Carter once said on TV " For the first time in history, the next 50 years wont be better than the past 50 years".....
As per valve choices, i was 62 when i choose mechanical, and one of the reasons "for me" among many others, was that "who knows what will be out there in 15 years", Warfarin is eassy to produce as it comes from natural sources and will always be there as or at least the last one to disappear...
But, hey, who knows, maybe J Carter was wrong, and we are heading right for the best time ever in the human race .......
As per valve choices, i was 62 when i choose mechanical, and one of the reasons "for me" among many others, was that "who knows what will be out there in 15 years", Warfarin is eassy to produce as it comes from natural sources and will always be there as or at least the last one to disappear...
But, hey, who knows, maybe J Carter was wrong, and we are heading right for the best time ever in the human race .......
You are paying experts to handle this for you, they should know what is the best mechanical valve for your condition and their surgical team. Trust their judgement, but verify what they tell you.
I have doubts about the future. In these days when they've stopped teaching about government in the public schools -- so people no longer understand the three branches of US Government and some seem to buy into the fact that the Legislative branch is a rubber stamp for the Executive, we've got real problems.
When they no longer teach the basics of math (or, perhaps they try, but it's much easier to pull out a phone and do the math than it is to actually THINK), and when you go to a store and the clerk has to pull out a phone to figure how much change is due, or what two of an item should cost.
When people no longer have to write - instead, they use some crazy shortcuts to reduce the number of characters in a tweet or message --- we have a problem.
Where, in the past, education was sometimes used to actually TEACH important things, much of this seems to be gone.
In the future, there will be two top tiers - the handful of programmers and engineers who don't lose teir jobs to artificial intelligence (and the people who make the computer hardware and software that runs it), and the hands-on people who do what we used to call 'trades.' It'll be people who can unclog your toilets, fix your electricity, actually BUILD and REPAIR things.
The rest of us will probably be relegated a bit lower, with robotics and AI taking over tasks that we formerly did; with farming resources mechanized and challenged by the ravages of global warming; with little value given to writers and thinkers (or some value given to a small handful to drift to the top).
I doubt that the next 50 - or even 20 or 30 will be better for most of us.
Medical research will continue; medical advancements will continue; perhaps our lives will be extended so we can enjoy life on an increasingly declining planet, with a majority of stupid (undereducated) people in the majority.
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